Drug-drug Interaction Study
Conditions
Brief summary
This is an open-label, single-sequence, drug-drug interaction study in healthy male and female subjects. There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may increase the exposure of montelukast, flurbiprofen, and digoxin.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a body mass index of 18.0 to 32.0 kg/m2, inclusive * Women of childbearing potential must agree to follow instructions for methods of contraception for the duration of the study
Exclusion criteria
* Any significant acute or chronic medical illness * History of arrhythmias or palpitations associated with dizziness or fainting * History of clinically relevant cardiac disease Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin | Predose and up to 168 hours post dose | Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin. | Predose and up to 168 hour post dose | Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020 |
| Safety | From dosing (Day 1) to Day 21 | Collection of adverse events and other physical parameters to assess safety |
Countries
United States
Outcome results
None listed